Laparoscopic visualization system

ABSTRACT

A Laparoscopic Visualization System comprising a sterile, self-contained, disposable apparatus used in medical procedures for heating and applying an anti-fog solution to the distal end of laparoscopes or surgical devices is presented. It additionally serves as an endoscopic lens protector and cleaner. An efficient heating and narrow range temperature control mechanism is used in combination with an anti-fog solution to provide clear visualization through a distal lens of the surgical device inserted into the system. The configuration prevents the anti-fog solution from spilling out of the system and is designed to also be used as a holder for the surgical scope, protecting the distal lens from impact with a shock absorbent outer shell, prior to, during, and after a medical procedure.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.15/384,855, filed Dec. 20, 2016, which is continuation of prior U.S.patent application Ser. No. 14/102,796, filed on Dec. 11, 2013, whichclaims the benefit of U.S. Provisional Patent Application Ser. No.61/879,668 filed on Sep. 18, 2013, which are hereby incorporated byreference in their entirety.

FIELD OF INVENTION

The current invention is directed to the field of Laparoscopic devices,particularly to a Laparoscopic Visualization System, used in minimallyinvasive surgery and other medical procedures. More particularly, thepresent invention relates to a significantly improved sterile, compact,disposable apparatus used for heating, applying anti-fog solution to,and protecting of the surgical scope distal lens prior to and during asurgical procedure.

BACKGROUND OF INVENTION

This invention generally relates to a device and system for heatingsterile liquid solutions prior to and during medical procedures forproducing optimum Laparoscopic visualization.

Laparoscopic surgery sometimes called keyhole or “Minimally InvasiveSurgery” (MIS), is a relatively new type of surgery that involves theintroduction of small incisions in a patient, (usually between 0.5 and1.5 cm) whereby access to the thoracic, abdominal or pelvic cavities isobtained by the use of a medical device called a trocar.

Prior to starting a surgical procedure a small incision is performed onthe patient whereby a trocar is inserted around the periphery of theincision. The trocar is then replaced with a cannula, device that allowsinsertion of medical devices. An insufflator also referred to as a pump,is used to inflate the cavity area with carbon dioxide thus providing ameans of viewing and creating space for the surgeon to perform themedical procedure. A special medical device called a laparoscope issubsequently inserted through the cannula whereby the surgeon initiallylooks inside the cavity area in question and determines the bestapproach for performing the medical procedure.

The invention of high resolution image processing devices hasrevolutionized laparoscopic surgery. When laparoscopic surgery isperformed surgeons have the option of using either a telescopic rod lenssystem (TRLS) which is a rigid device connected to a high resolutionimage processing device or a digital laparoscope which uses a chargecoupled device. A charged couple device or CCD is often used in imageprocessing devices. Its advantage is that it is small, and compact. Itcaptures images based on the strength of the electric charge receivedfrom an image. The stronger the source of received light, the strongerthe electric charge created. This electronic information is thentransferred electrically to a processing device that converts thereceived signal to a pixel intensity, thus creating a smooth imagescreen. The advantage in using this system is that it is very small andflexible thus providing maneuvering room for the surgeon to look intosmall, difficult to reach areas.

Prior to the invention of Laparoscopic surgery, patients were subject tomajor invasive procedures, which increased pain, scaring, hemorrhaging,trauma, complications and long recovery times. Through the use of smallincisions most of these setbacks have been minimized. The modern use ofimaging devices has opened up a window for surgeons to safely view theinside cavities of a person and perform many types of surgeries.

The biggest problem surgeons face with Laparoscopic procedures is beingable to see clearly once they are inside a cavity, such as the abdomenof their patient. Clouding is a problem that occurs, caused by contactof the distal lens with body fluids, burnt tissue and other debris,making it difficult for the surgeon to see clearly.

Therein lies the problem. Thus there exists in the industry a need for aLaparoscopic Visualization System that is easy to use, and providesexceptional clarity. There are bulky devices in the industry forcleaning the lenses of Laparoscopes but they are not practical. Somesurgeons have been known to place their Laparoscopes into a warm bucketof distilled water and dunk it every time cleaning is needed. In somecountries this procedure has been banned. The present inventionovercomes these problems by providing a Laparoscopic VisualizationSystem that is efficient and well suited for quick and dependable usage.

SUMMARY OF INVENTION

The following patents are incorporated in their entirety by reference:U.S. Pat. No. 7,080,641 B2, a Method and Apparatus for Heating SterileSolutions during Medical Procedures, U.S. Pat. No. 7,311,660 B2, aMethod and apparatus for Heating and Applying Warm Anti-fog Solution toEndoscopes As Well As Distal Lens Protector, U.S. Pat. No. 7,803,109 B2,Method and Apparatus for Protecting Distal Lens of Endoscopes, and U.S.Pat. No. 8,152,717 B2, a Device for White Balancing and Applying AnAntifog Agent to Medical Videoscopes prior to Medical Procedures.

The current application is directed toward a Laparoscopic VisualizationSystem used in the cleaning of lenses of Laparoscopes/Endoscopes byapplying a warm anti-fog solution to the distal lens of the device. Theanti-fog solution is quickly and efficiently heated and maintained atbody temperature to minimize fogging. The system also protects thedistal lens. The Laparoscopic Visualization System also has theadditional function of providing a means of white balancing.

Significant improvements have been made to the following elements of theLaparoscopic Visualization System. Among them are: a significantlyimproved heating element or coil, an ergonomic inner frame, an improvedthermoswitch which maintains a more stable temperature within thedevice, an improved power source, a more efficient heating circuit, anefficient low consumption indicator, an efficient printed circuit board,an efficient can assembly, a specialized reducer and an improved valveassembly. These significant changes have dramatically reduced humanerror and significantly improved control and efficiency of the device.

The present invention discloses an apparatus that combines the benefitsof both heat and anti-fog solution, providing superior anti-foggingduring the entire surgical procedure. The apparatus is compact anddesigned to be placed over the distal lens prior to and during a medicalprocedure. By allowing the lens to bathe in the warm anti-foggingsolution, as opposed to just wiping it in the solution, theeffectiveness of the anti-fogging solution is greatly increased. Theapparatus includes a solid foam outer shell with an interior dividedinto several compartments. A reservoir in the center of the apparatus isfilled with an anti-fog solution of a surfactant in water. TheLaparoscopic Visualization System is found useful when a distal end of asurgical instrument is inserted through a self-sealing valve of thesystem, and is submerged within the anti-fog solution within thereceptacle. The instrument is simultaneously heated and bathed in thewarm surfactant solution in water. The hard frame and soft interior ofthe can assembly create a protective barrier around the delicateinstrument's distal end. When not in use, the scope can rest inside theLaparoscopic Visualization System, protecting the scope from damagepotentially caused by other instruments and trays. Protecting the scopeis a very beneficial attribute since scopes are very expensive and arefrequently scratched or damaged during procedures, costing hospitals agreat deal of money. By heating the solution and the instrument, thesignificant temperature difference between the interior of the body(98.6.degree. F.) and the room temperature of the instrument areeliminated. This temperature normalization inhibits the condensation ofmoisture, which occurs upon inserting the cool scope into a warm bodycavity. By combining heat with the use of an anti-fogging solution,fogging is prevented from occurring at insertion and duringcauterization procedures when smoke and heat are generated within thebody cavity.

The main power source may be either an internal or external type. Asterile self-contained battery source is the preferred embodiment. Inthe preferred embodiment a power supply consisting of three (3) AAbatteries, are used and secured into a battery pack. Among theadvantages of using batteries are their cost effectiveness andefficiency. By removing the bottom cover and pulling out the batterypack, the batteries can be disposed of in a safe and environmentallyfriendly manner. The advantage of using an internal batteryconfiguration is that it provides a self-contained sterile environmentfacilitating its introduction into the operating room. Any typicalbattery can be used such as NiCad, Lithium, and Alkaline. In anotherembodiment an external AC (plugged) power source may be used. Among itsadvantages is that it is cost effective for maintenance over longerperiods of time. In the ideal embodiment, the battery source should lastas long as the surgery, a minimum of 1 hour and in the preferredembodiment, 4-6 hours. The battery configuration is easier for the userto employ, because the batteries are pre-installed and already in asterile environment. As a means of holding the batteries together theycan be spot welded together or into a battery holder. The advantage ofspot welding is that it provides a means of securely holding thebatteries together and making the connections more stable and permanent;the disadvantage is that it increases manufacturing time. In anotherembodiment custom batteries can also be used. Once the procedure iscompleted the Laparoscopic Visualization System can be safely disposedof. The batteries may also be pulled out from the bottom and properlydisposed of.

In the present invention basic circuitry, there is a power sourceconnected to an On/Off switch. The On/Off switch is connected in serieswith a parallel circuit consisting of a first path having a heating coilin series with a thermoswitch and a secondary path consisting of aresistor in series with a light emitting diode (LED). The integratedcircuitry is located on a printed circuit board (PCB). The componentscan also be individually assembled and connected without the use of aPCB. The PCB is part of the mechanical assembly used to form theLaparoscopic Visualization System shape. The main advantage of theprinted circuit board is its reduced wiring and compact circuitry. Thiscircuitry design has been found to be the most effective for the presentinvention. This simplified construction reduces human error and failureby compartmentalizing individual parts into pre-assembledsub-assemblies.

A blue LED is used for indication. The wavelength of the blue LED is inthe range of 400 nm which is among the most energetic. Since an LEDproduces light in a narrow band of wavelengths phosphors are sometimesused to improve the spectrum of the light produced. It is also possibleto combine several different LEDs, each producing a different wavelengthto indicate different stages of the battery cycle such as when the levelof power is decreasing.

The Laparoscopic Visualization System provides optimum visualizationduring laparoscopic or robotic surgery. The Laparoscopic VisualizationSystem is used to keep the lens defogged and clean from the opening ofan operation through its close. Additionally it provides a true whitebalancing feature for better resolution. When the LaparoscopicVisualization System is activated and affixed to the patient's drape theLaparoscope is easily defogged and can be cleaned numerous times withthe use of just one hand in as little as 5 seconds providing optimumvisualization for surgery from opening to close. Most importantly theLaparoscopic Visualization System provides an innovation that helpsprovide improved patient care.

The Laparoscopic Visualization System works in the following manner. Thecompact unit is affixed to a patient's drape allowing quick access tothe defogging/cleaning system using only one hand. In just 5 minutes,the anti-fogging solution warms to approximately 120.degree. F. to warmthe endoscopic camera distal lens. The liquid quickly breaks down fatsand tissue debris adhered to the lens. The Laparoscopic VisualizationSystem is compatible with laparoscopes from 5 mm to 12 mm in diameter.The liquid is maintained warm for up to 6 hours. The LaparoscopicVisualization System can also provide true white balancing for bettercolor visualization needed in Laparoscopic surgery. A microfiber padincluded with the unit is used to remove tissue remnants withoutscratching or smudging the valuable laparoscope or robotic lenses. Twosoft Micropad® towels can be provided in the form of a kit to helpremove any persistent tissue remnants on the lens of the surgical devicewithout leaving lint or smudging. The Micropad® towels are used toreplace the use of coarse surgical gauzes which are harder on the lens.The Micropad® towels are also radio opaque helping to find them in theunlikely event they are ever left inside a patient. A TrocarWipe™elongated cleaner is included in the kit to help clean the inside of thetrocar/cannula. As mentioned earlier when not in use the laparoscope canbe placed on standby inside the Laparoscopic Visualization System,maintaining cleanliness and protecting the lens. This positioning insidethe Laparoscopic Visualization System prevents accidental burning of thepatient caused by the high temperature created by the Laparoscope tip.The Laparoscopic Visualization System is the only system that keepslaparoscopes defogged and cleaned from start to close.

In another embodiment a cloth like material is placed inside the TopValve Cover to absorb any liquid that may leak out of the InnerAssembly. This cloth like absorbent material can take a shape similar tothe inside of the foam body.

An additional feature of the Laparoscopic Visualization System is itsability to absorb heat generated by the high intensity laparoscopiclight source. When not in use, placing the laparoscope inside the heatedcan assembly reduces the possibility of small fires and patient burnscaused by the high performance light source resting on the paper drapesor patient.

There is a need in the field for a reliable, efficient LaparoscopicVisualization System. The present invention overcomes the deficienciesof the known art and the problems that remain unsolved by providing amethod and apparatus for efficiently heating and cleaning laparoscopicdevices in a sterile environment.

These and other aspects, features and advantages of the presentinvention will become more readily apparent from the attached drawingsand the detailed description of the preferred embodiments, which follow.

BRIEF DESCRIPTION OF DRAWINGS

The preferred embodiments of the invention will hereinafter be describedin conjunction with the appended drawings provided to illustrate and notto limit the invention, in which:

FIG. 1 presents an isometric view of the Inner Assembly of theLaparoscopic Visualization System.

FIG. 2 presents an exploded Perspective view of the LaparoscopicVisualization System.

FIG. 3 presents an exploded Isometric view of the LaparoscopicVisualization System Inner Assembly.

FIG. 4 presents a top view of the Laparoscopic Visualization SystemInner Assembly.

FIG. 5 presents a Perspective view of the Top Cap Assembly.

FIG. 6A presents a Top view of the Laparoscopic Insertion Valve.

FIG. 6B presents a Side Isometric view of the Laparoscopic InsertionValve.

FIG. 6C presents a Cross Sectional view through the Laparoscopicinsertion Valve.

FIG. 7A presents a Top view of the Laparoscopic Leakage Reducer.

FIG. 7B presents a Side Perspective view of the Laparoscopic LeakageReducer.

FIG. 7C presents a Top view of the Laparoscopic Leakage Reducer.

FIG. 8A presents a Backside Isometric view of the LaparoscopicVisualization System Inner Assembly.

FIG. 8B presents a Side view of the Laparoscopic Visualization SystemPCB.

FIG. 8C presents a Front view of the Laparoscopic Visualization SystemPCB showing its components.

FIG. 9A presents a Side Perspective view of the LaparoscopicVisualization System Body Assembly.

FIG. 9B presents a Top Perspective view of the LaparoscopicVisualization System Body Assembly.

FIG. 9C, presents a Bottom Isometric view of the LaparoscopicVisualization System Body Assembly.

FIG. 10 presents a Perspective view of the Bottom Cover Assembly.

FIG. 11 presents an Electrical schematic of the preferred embodiment.

FIG. 12 presents a graph showing temperature variations with bothinsulated and uninsulated thermo switches of the System.

Like reference numerals refer to like parts throughout the several viewsof the drawings.

DETAILED DESCRIPTION

The following detailed description is merely exemplary in nature and isnot intended to limit the described embodiments or the application anduses of the described embodiments. As used herein, the word “exemplary”or “illustrative” means “serving as an example, instance, orillustration,” Any implementation described herein as “exemplary” or“illustrative” is not necessarily to be construed as preferred oradvantageous over other implementations. All of the implementationsdescribed below are exemplary implementations provided to enable personsskilled in the art to make or use the embodiments of the disclosure andare not intended to limit the scope of the disclosure, which is definedby the claims. For purposes of description herein, the terms “upper”,“lower”, “left”, “rear”, “right”, “front”, “vertical”, “horizontal”, andderivatives thereof shall relate to the invention as oriented in FIG. 1.Furthermore, there is no intention to be bound by any expressed orimplied theory presented in the preceding technical field, background,brief summary or the following detailed description. It is also to beunderstood that the specific devices and processes illustrated in theattached drawings, and described in the following specification, aresimply exemplary embodiments of the inventive concepts defined in theappended claims. Hence, specific dimensions and other physicalcharacteristics relating to the embodiments disclosed herein are not tobe considered as limiting, unless the claims expressly state otherwise

The Laparoscopic Visualization System or device 10 FIG. 1 comprises anouter shell 200 FIG. 2 made of a soft foam, rubber, or other shockabsorbing material. Not only is the material of the shell shockabsorbing, but it serves as a thermal insulator as well, helpful notonly in maintaining the temperature of the structures therewithin butalso keeping heat from escaping from within the shell. The shell 200 isdesigned to protect a distal lens of a laparoscope or other scope (notshown) from damage prior to, during, and after a surgical procedure.

Interior major components of the Laparoscopic Visualization System 10are illustrated in their assembled manner in FIG. 1. The primaryassembly is called the Inner Assembly. It encompasses all the majorelements of the Laparoscopic Visualization System 10. An indicator 105is always used for differentiating when the device is on or off. In thepreferred embodiment the Laparoscopic Visualization System 10 uses ablue emitting LED 105, as the indicator. Blue is the preferred colorbecause it is easily seen in the operating room. White is not thepreferred LED color choice because it is not always readily visible.Among the many advantages of using an LED 105 as the main indicator, areits low cost, low and efficient power consumption, its resistance tovibration and shock damage, its low heat generation, its insensitivityto lower temperatures such as in an operating room, its ability to beunaffected by on/off cycling and its long life cycle. The LED 105 mayalso serve to warn when the batteries are becoming weak by flashingintermittently. In a further embodiment it is possible to have severalLEDs 105 or one multifunctional LED 105, as the indicator 105. In adifferent embodiment (not shown) a small light bulb or temperaturechange color sticker can be used.

A printed circuit board (PCB) 125 is used for containing all operatingcircuitry for the assembly 10 and a resistor 110 is incorporated intothe PCB 125 and has a resistance of between 10 and 1000 ohms. One of thepurposes of the resistor 110 is to control the current passing throughthe LED 105, which in turn controls the brightness of the LED 105.Another factor affecting the brightness of the LED 105 is the length ofHeating Coil 145. By extending the length of the Heating Coil 145, theresistance increases thus increasing the current going to the LED. Theresistors 110 value must also be changed in order to maintain the samebrightness to the LED 105. As the length of heating coil 145 isextended, power production drops. This is demonstrated by applying Ohmslaw E=I×R, where the voltage E remains constant in a parallel circuit.By increasing the length of the heating coil 145, the resistanceincreases, causing the branch current to decrease. This affects thebrightness of the LED 105 in the adjacent parallel circuit. As the coil145 resistance increases the current in the adjacent parallel circuitalso increases causing the LED 105 to become brighter. A resistor inseries with the LED helps to control the brightness. By applying thepower formula P=V.sup.2/R, it is clearly demonstrated why less power isproduced in this branch. In another embodiment, no resistor or LED isused.

One of the major advances in the present Laparoscopic VisualizationSystem 10 is the arrangement and location of a Thermoswitch 115. Throughempirical testing and analysis, it has been determined that the mostefficient and stable temperature control of the anti-fog solution isachieved when the Thermoswitch 115 is positioned as shown in FIG. 3directly over the Heating Coil 145, and just below the level of theliquid (most preferably water containing a surfactant for conveniencereferred to as surfactant 190). The Laparoscopic Visualization System 10is maintained between 50-70.degree. C. (122-158.degree. F.).Functionality determines the temperature range selected; Le, defogging,cleaning, etc. Outstanding results were ultimately obtained by providinga wrapping material 116 in the form of a pellicle that serves as acompression cuff for pressing the thermoswitch 115 into close physicaland thermal transfer relationship with both the can assembly 150 and theheating element 145. The wrapping material 116 has four primaryfunctions: It stabilizes the thermoswitch 115; element 145 and canassembly 150 against shock and vibration; it holds the thermoswitch 115in heat transfer relationship with both the element 145 and the fluid inthe can assembly 150; it acts as a thermal insulator by reducing heatloss; and finally it secures the thermal transfer switch 115, coil 145and can assembly 150 together as a unit. In a preferred form, thewrapping material 116 is a pellicle of heat shrink plastic such as anysuitable grade of thermoplastic heat shrink resin in the form of acircular band about 1¼ inches in diameter which after being slipped overthe can assembly 150 and thermoswitch 115 is warmed with a heat gununtil it shrinks sufficiently to tightly compress the thermoswitch 115securely and in thermal transfer relationship with the coil and canassembly 150. We prefer to use a heat shrink pellicle that has athickness of at least about 0.005 inch since it was found to also beeffective as a thermal insulator in enhancing the temperature stabilityof the thermoswitch 115 while at the same time maintaining efficientheat transfer from the fluid and coil 145 to the thermoswitch therebyimproving overall thermal efficiency of the complete system as describedmore fully in connection with FIG. 12 thereby substantially prolongingbattery life. The ideal temperature range for the LaparoscopicVisualization System 10 will depend on several factors, among them arethe length of heating coil 145, the location of the heating coil 145,and the amount of heat wrapping material 116 covering the Thermoswitch115. When wrapping material 116 is used in accordance with the presentinvention, outstanding temperature stability is achieved, asdemonstrated in the chart of FIG. 12. The two saw tooth lines showtemperature variations where no insulation surrounds the Thermoswitch115. In contrast the narrow edged lines indicate a stable bettercontrolled temperature variation. Single or double insulation can beused for covering the Thermoswitch 115.

In the preferred embodiment, there is minimal insulation between theThermoswitch 115, and Heating Can Assembly 150, resulting in better heattransference to the antifog solution inside the Heating Can Assembly 150from the heating coil 145 coiled there around. In the preferredembodiment, Thermoswitch 115 is a mechanical type switch. Theconfiguration of the Main Framework 140 may require the Thermoswitch 115to be off center. The Main Framework 140 is specially designed, sizedand configured to provide a means of securely attaching and holding allthe components in the correct orientation. The Thermoswitch 115 may bein the form of a temperature sensor made of bi-metallic material or athermocouple temperature sensing device in an IC or microcontroller. Itmay also be any heating resistive mechanism. In the preferredembodiment, a bimetallic strip type Thermoswitch 115 is used.

The bimetallic strip type Thermoswitch 115 is used to convert atemperature change into a mechanical displacement. The bimetallic striptype Thermoswitch 115 comprises two pieces of different metals whichexpand at different rates as they are heated. The bimetallic strip typeThermoswitch 115 can be made of steel and copper, or in some cases steeland brass, joined together throughout their lengths by riveting, brazingor welding. The different expansion rates force the flat strip to bendin one direction when heated, and in the opposite direction when cooledbelow the initial temperature. The metal with the higher coefficient ofthermal expansion is usually placed on the outer side of a curve so thatwhen the Thermoswitch 115 is heated, it displaces further.

Moving the heating coil 145, up or down the along a length of theheating can assembly 150 affects the ultimate temperature the antifogsolution reaches. The Thermoswitch 115 is designed to open and close atpre-determined temperatures. If the Thermoswitch 115 is situated awayfrom the heating coil 145 and the heating coil 145 is not positioned ator below the level of the antifog solution 190, more power will have tobe generated by Power Source 205 of FIG. 2, to cause the Thermoswitch115 to reach the desired cut off temperature. This explains why theorientation of the Thermoswitch 115 is so critical and why having it inthe proper location significantly extends the useful life of theLaparoscopic Visualization System 10. The most important features of theThermoswitch 115 are its quick temperature response time andself-resetting characteristics.

FIG. 1 also shows pin connectors 120 which connect the Heating Coil 145to the PCB 125, completing the circuit. The improved simple connectionallows quick assembly and significantly reduces the amount of humanerror during assembly. The Heating Coil 145 is preferably a 35 gaugecopper enamel coated wire; copper being preferred. Nichrome can also beused, but in general any wire capable of conducting current, or anyresistive heating element can also be used. The length of the heatingcoil 145 can be between 5-14 feet. In the preferred embodiment, thelength is between 7-11 feet. This length provides the best balance andmost efficient means to quickly reach the desired warming temperature.In order to provide the most efficient transfer of heat, the HeatingCoil 145 needs to be tightly coiled in a single layer along the outsideof Heated Can Assembly 150. By not using a multilayered winding, hotspots and shorting of the heating coil 145 are avoided. Each loop ofcoil 145 must be adjacent to and in contact with the next to generate aneven, controlled amount of heat. The Heating Coil 145 is engaged throughan On/Off switch 130 which is actuated through a lever 142 connected toan elongated side arm 148, actuated by a button 950 of FIG. 9B, on outershell 200. The user just needs to depress the button 950 and the On/Offswitch 130 will turn on the device 10, will turn on the LED indicator105, and begin warming the Heating Coil 145. The main connection fromPower Source 205 to the On/Off switch 130 is made through a connector191, FIG. 2 on Printed Circuit Board 125 of FIG. 1. The lever 142, ifnecessary, may also be actuated by pushing upwardly thereon from below,within the shell 200 to turn the Laparoscopic Visualization System 10off.

An improved Main Framework 140 of FIG. 3 is used to support theintegrated parts comprising the Inner Assembly 100. The Inner Assembly100 integrates the Printed Circuit Board 125, the Heating Can Assembly150, and Beveled Valve Cap 160 and the lever 142 on the main framework140, as well as for allowing positioning of the wrapping material toheating coil 145 within its confines.

FIG. 2 provides an exploded view of the internal elements of theLaparoscopic Visualization System 10 within shell 200. The plastic orceramic beveled Valve Cap 160 is used to lock the Insertion Valve 170 inplace and can be held in place by gluing, applying wrapping material orany other industry standard method. A cup 180, made of a firm yetflexible material, such as a foam, for example, is seated within a basearea of the heating can assembly 150 and is used to protect the distallens of a Laparoscope from damage and scratching when inserted. An extrafeature of the cup 180 is that it can also be used for white balancing.The cup 180 may also be made of rubber, cloth, sponge or felt materials.

The main framework 140 holds the key elements of the LaparoscopicVisualization System 10. When the On/Off Button 950 of FIG. 9A isdepressed, lever 142 which mechanically engages and moves an elongatedsidearm 148 in functional communication with the internal On/Off switch130 turning it on, thus activating the Laparoscopic Visualization System10. A Battery Holder 195 is used to hold three AA batteries 205, formingpower source 205, in place. Battery Holder 195 provides power to theAssembly 10, through power connector 191. An optional battery Pull Tab210 of FIG. 2 is used to provide a means of extracting the batteries.The Laparoscopic Visualization System shell 200 is covered along thebottom with a Bottom Cover Assembly 900. The Laparoscopic VisualizationSystem Bottom Cover assembly 900 has the option of having an adhesiveStrip 905 to secure the Laparoscopic Visualization System shell 200, tothe patient or an anchoring site. The Laparoscopic Visualization Systemshell 200 engages an external Laparoscopic Reducer 980 FIG. 2. Thisreducer can also be custom sized to fit custom made laparoscopes.

The framework 140 includes top and bottom slots 201 of FIG. 1, whichengage around the lever 142 in a manner where it is slideable between anup (off) position and a down (on) position, relative to an actuator 202of the on/off switch 130 which engages within a slot 203 formed in sidearm 148 of the lever 142.

In the preferred embodiment the Laparoscopic Visualization System 10 ofFIG. 2 uses surfactant 190 in the form of a sterile fluid 190, howeversterile water, sterile saline, or any sterile anti-fog solution may alsobe used. In the preferred embodiment, 5 ml of liquid 190 is reserved inthe canister 150. Evaporation of the liquid 190 in the canister 150 isnot a concern because of the enclosed environment within canister 150.Another important consideration is that the surfactant 190, with respectto the orientation of the heating coil 145, must be such that heat cantransfer effectively, including when the canister 150 is in a horizontalposition. It will be understood that the duckbill valve 174 in inset,along a top level of the liquid 190 so that, when placed on its side,the main volume of the liquid remains within a small area beneath theduckbill valve 174 and in contact with the heating coil 145 to maintainthe temperature thereof as constant as possible.

FIG. 3 illustrates a detailed internal view of key elements of InnerAssembly 100. The beveled Valve Cap 160 holds the Laparoscopic InsertionValve 170 in place over the entrance to the Heated Can Assembly 150,with the Printed Circuit Board 125 the Heating Coil 145 being mounted tothe Main Framework 140 as well, forming the inner assembly 100.

The Inner Assembly 100 of FIG. 3 includes beveled Valve Cap 160 which isheld in place by at least two Valve Cap Elongated Prongs 155. The Prongs155 are slightly offset, allowing the beveled Valve Cap 160 to securelylock into place over an entrance to heating can assembly 150 formed by aflexible insertion Valve 170, which is used to guide a laparoscope intoheating can assembly 150. At least one Insertion Valve Expansion Orifice172 is provided along an inner periphery of the insertion valve 170 tocompensate for the different diameters of Laparoscopes used. The atleast one insertion Valve Expansion Orifice 172 also permits air toescape from the Heated Can Assembly 150 upon insertion of a laparoscope.

The Heating Can Assembly 150 in its preferred embodiment is made ofstainless steel. It is constructed of a biocompatible material and isinexpensive to produce. In other embodiments it can be made of Plastic,Aluminum, Ceramic or a combination thereof or of other metals that haveexcellent heat conductivity. The thickness of the Heated Can Assembly150 is an important consideration because it determines the heatingproperties. The thickness of the Heated Can Assembly 150 can be between0.1 to 0.75 mm. In FIG. 3 top 161 of the Heating Can Assembly 150 isslightly flared allowing the beveled Valve Cap 160 to have a tighter andbetter fit when secured thereon.

The Insertion Valve 170 includes several important qualities. Among themare its construction, being made of a flexible rubber or plasticmaterial that permits instruments whose diameters are between 2-12 mm tobe inserted snugly, thus permitting only minimal leakage. TheLaparoscopic Insertion Valve 170 must be designed to allow easy passageof other medical devices, and it is self-sealing once the medicaldevices are removed. In the preferred embodiment the LaparoscopicInsertion Valve 170 helps to control pressure in the heating canassembly 150, which can be accomplished by any suitable means, such asby the provision of a compressible bladder 500 of FIG. 6B, or a one wayventing or duckbill valve 174.

FIG. 4 illustrates a top view of Inner Assembly 100. The beveled ValveCap 160 has at least one cut away recess 196 that is better seen in FIG.3. Recess 196 permits the LED 105 to fit closely to the Valve Cap 160.The cut away recess 196 also reduces the overall size of the InnerAssembly 100. How the PCB 125 mechanically engages the Main Framework140 is also illustrated. FIG. 4 shows the symmetry and ergonometry ofthe beveled Valve Cap 160 with respect to the Main Framework 140.Insertion Valve 170 further includes a normally closed duckbill or oneway venting valve 174 comprising two mating flexible sections 175, themating edges 176 of which is closed when nothing is inserted into theheating can 150, the duckbill valve 174 being spaced downwardly from thebeveled cap 160, at a position just above the level which liquid 190reaches, the duckbill valve 174 being in a normally closed position.

FIG. 5 Illustrates a Perspective view of the beveled Cap Assembly 160. Asmooth Beveled Valve Cap Opening 165 is used to help guide thelaparoscope into the Heated Can Assembly 150. A side wall 167 of theValve Cap 160 is designed so that its height is sufficient to provide asecure fit over the Insertion Valve 170 of FIG. 6B. There are at leasttwo Valve Cap Elongated Prongs 155 symmetrically located on the bottom171 of the Valve Cap 160 which are used for securing the Valve Cap 160to the Main framework 140 over the entrance to Heating Can Assembly 150.

FIG. 6A illustrates a Top View of the Laparoscopic Insertion Valve 170.The Insertion Valve 170 and duckbill valve 174 provide a point of entryfor the insertion device. A special Insertion Valve Expansion Bladder500 of FIG. 6B is provided to compensate for the pressure displacementscaused by the insertion of laparoscopic devices into the canister 150and to compensate for the expansion that takes place when the liquid 190is heated. The compressible valve expansion bladder 500 provides amechanism for pressure control within canister 150.

FIG. 6B illustrates a Side View of the Laparoscopic Insertion Valve 170,with expansion bladder 500 protruding. The expansion bladder 500 servesa further purpose, for the insertion of a leakage Reducer 700. Theleakage Reducer 700 is a major improvement to the LaparoscopicVisualization System 10. It assists in preventing leakage of liquid thatmay have escaped from the Insertion Valve Duck Bill 174 of FIG. 6B thatexpands to allow a Laparoscopic device to enter and provides a tight fitthere around, inside the Heated Can Assembly 150.

FIG. 7A, illustrates a top Isometric View of the Laparoscopic LeakageReducer 700. The Leakage Reducer 700 provides an opening for theInsertion Valve Expansion Bladder 500 of FIG. 68 to securely engagewithin the canister 150. The Leakage Reducer 700 locks into place withthe Laparoscopic Insertion Valve 170 of FIG. 6A, providing a secondaryleakage preventing structure and a tool used for accommodating differentsized medical devices. The leakage Reducer 700 can be permanentlyattached as one piece or as two separate pieces.

In the preferred embodiment the attached tethered Reducer 980 of FIG. 2connects at Recessed Reducer Attachment Area 965 of FIG. 9C. It issnapped into place through the recessed opening 175 of FIG. 9A,providing a firm snug fit for Laparoscopic devices. This furtherminimizes the leakage potential for the surfactant 190.

FIG. 7C illustrates a U-shaped projection on the inner surface ofretainer 700 that at least partially surrounds aperture 705 to serve asa spacer 710 to keep a pressure release aperture in the leakage reducer700 from being obstructed, e.t. by a part of valve 170 when the surgicalscope is inserted into the chamber. The U-shaped spacer 710 provides aunique means for enabling air to escape with little or no loss of thesurfactant liquid 190.

FIG. 8A shows the orientation of the PCB 125 and the inner assembly 100of Laparoscopic Visualization System 10. A small gap defines the outerchamber within the Main Framework 140, and the Heating can assembly 150,allowing the heating coil 154 to be received within the main framework140.

FIGS. 8B and 8C show the compactly designed simple PCB 125,incorporating the On/Off switch 130, the LED 105, the Resistor 110,illustrating the location and orientation of the Thermoswitch 115, andthe Heating Coil connector pins 120 as well. This ergonomic designdramatically reduces the potential for human error during assembly. Theintegration of the above defined structures into the PCB 125significantly improves quality control, manufacturing and assembly ofthe Laparoscopic Visualization System 10. A PCB battery connector 192 isprovided for quickly connecting the battery pack 195 connector 191. APCB locking feature 147 of FIG. 8A is also employed to help secure thePCB 125 to the main framework 140.

FIG. 9A illustrates a side view of the shell 200 of the LaparoscopicVisualization System 10. Recessed opening 175 shown allows and helpsguide a Laparoscope into the Heating Can Assembly 150. A bottom cover910 of Bottom Cover assembly 900 can be used for securely attaching theLaparoscopic Visualization System 10 to a suitable structure within thesurgical field during laparoscopic procedures. An endoscopic LensCleaning Pad 960 attached via a rear flange 961 is used to clean theLaparoscopic lens before or after insertion into the Heated Can Assembly150. The circular opening 955 is formed as part of the housing assembly.The blue LED 105 indicator projects light through a circular opening 955in the shell 200.

FIG. 9B illustrates a Perspective view of the shell 200 of theLaparoscopic Visualization System 10. The figure demonstrates how userfriendly the Laparoscopic Visualization System 10 is to the surgicalteam with its simple design, letting the user know when it is activated,by illumination means and warming the liquid 190 used for cleaning thelens.

FIG. 9C illustrates an Isometric view of the bottom cover assembly 900of Laparoscopic Visualization System 10. An optional additional RecessedReducer attachment area 965 may be incorporated to compensate forattaching different sizes of valve reducer 980. A Bottom HousingAssembly Opening 970 is configured to easily allow the inner assembly100 of the Laparoscopic Visualization System 10 to be inserted into theshell 200 through the bottom. Battery Holder Insertion Opening 975 isspecially cut out to allow Battery Holder 195 to snugly and frictionallyfit into the shell 200, and glue or other adhesives can be applied tofurther secure the inner assembly 100 in the shell 200.

FIG. 10 illustrates a Perspective view of the Bottom Cover Assembly 900.A Bottom Cover adhesive 905 can be used to attach to Bottom Cover 910 tothe body assembly 200. Its purpose is to provide means for securelyattaching the Laparoscopic Visualization System 10 to a stationaryobject, preferably within the surgical field. A Bottom Cover LockingInsert 920 is also provided for attaching the Bottom Cover Assembly 900to the shell 200. A special Housing Attachment Tab 915 is designed toclip onto or grab onto a bottom surface of the heating can assembly 150.A specially designed Clamping Tab 925 is also provided for attaching theLaparoscopic Visualization System 10 to a secure object during surgery.A Bottom Support Member 930 is designed at an angle and is used forholding the Inner Assembly 100 in place. A Bottom Battery Locking Latch940 is used to provide an attachment for the Bottom Cover assembly 900.A Bottom Battery Angled Support 945 is used to secure Battery holder 195inside the shell 200.

In a further proposed embodiment, the Laparoscopic Visualization System10 may incorporate brushes or other mechanical means for cleaningvarious Laparoscopic instruments. The warmed liquid 190 in the HeatedCan Assembly 150 may also be used to warm and clean other types ofLaparoscopic Instruments, thus acting as a multipurpose instrumentcleaner.

FIG. 11 presents an electrical schematic of the preferred embodimentwherein all the essential elements are shown. A power supply 205consisting of three (3) AA batteries 205 is the source that drives thecircuitry. An on/off switch 130 in the normally open position isconnected in series with the simple parallel circuit presented on thePCB 125 that provides heating and “On” indication to the LaparoscopicVisualization System 10. Further, normally closed Thermal Switch 115connects in series with the Heating Coil assembly 145. The Heating Coil145 is connected to heating coil pin connectors 120 at points asillustrated. When the temperature of the Heating Can Assembly 150reaches a predetermined temperature, it causes the Thermoswitch 115 toopen, breaking the electrical current going into the heating coilassembly 145. Whenever the temperature within heating can assembly 150drops below a predefined lower temperature threshold, the Thermoswitch15 closes and allows current to flow into the Heating Coil 145 to warmliquid 190. Although in the preferred embodiment the power source 205 isa DC source it does not preclude use of an AC power source.

In a further embodiment thermal epoxy 117 of FIG. 1, may be used forbetter transference of heat from the heating coil 145 to the thermalswitch 115. One advantage of using thermal epoxy 117 is that it allowsthe bi-metallic Thermoswitch 115 to freely expand and contract withoutany physical restriction or hindrance.

As will be recognized by those of ordinary skill in the pertinent art,numerous modifications and substitutions can be made to theabove-described embodiments of the present invention without departingfrom the scope of the invention. Accordingly, the preceding portion ofthis specification is to be taken in an illustrative, as opposed to alimiting sense.

What is claimed is:
 1. A laparoscopic visualization system comprising: ahousing comprised of an insulating, substantially rigid material, thehousing having sidewalls defining a plurality of sidewall chambers and acentral chamber, an outer surface of the housing including an inletincluding a normally closed valve therein, the inlet communicating withthe central chamber to allow a distal end of a surgical scope to beinserted into the central chamber through the inlet, the valve sealingaround the distal end of the surgical scope when inserted and the valveclosing off the central chamber upon removal of the surgical scopedistal end therefrom; the central chamber being configured to allow adistal end of a surgical scope to be received therein when insertedthrough the inlet and to be submerged in and heated by a warmedanti-fogging liquid solution within the central chamber; a heating coilcoiled around the central chamber for heating an anti-fogging liquidsolution contained within the central chamber in a narrow range,controlled manner to clean and warm a distal lens of the surgical scopesubmerged in the heated anti-fogging solution; and electrical circuitryincluding a thermoswitch for controlling the temperature of the liquidsolution within the central chamber, wherein the heating coil ispositioned between the central chamber and a layer of wrapping materialwithin the housing.
 2. The laparoscopic visualization system of claim 1wherein the heating coil is positioned below the level of liquidsolution within the central chamber.
 3. The laparoscopic visualizationsystem of claim 1 wherein the laparoscopic visualization system isdisposable.
 4. The laparoscopic visualization system of claim 1 furthercomprising: an on/off switch provided for controlling activation of theelectrical circuitry; and means for indicating the on condition of thesystem.
 5. The laparoscopic visualization system of claim 1 wherein thewrapping material is a circular pellicle surrounding the central chamberthat presses against the outer surface of the thermoswitch for urgingthe thermoswitch toward the central chamber.
 6. The laparoscopicvisualization system of claim 1 wherein the thermoswitch is positionedover the heating coil.
 7. The laparoscopic visualization system of claim1 wherein thermoswitch is in heat-conductive relationship with thecentral chamber.
 8. The laparoscopic visualization system of claim 1wherein the thermoswitch is configured to control the temperature of theliquid solution within the central heating container within apredefined, narrow range of temperatures so as to maintain thetemperature of the liquid solution substantially constant.
 9. Thelaparoscopic visualization system of claim 1 wherein the wrappingmaterial is configured to press the thermoswitch into close physical andthermal transfer relationship with the central chamber.
 10. Thelaparoscopic visualization system of claim 1 further comprising meansfor reducing pressure within the central chamber when a distal end ofthe surgical scope is inserted into the central chamber to keep liquidsolution from being forced out of the central chamber.
 11. Thelaparoscopic visualization system of claim 1 wherein a thermal epoxy isinserted between the heating coil and the thermoswitch.
 12. Thelaparoscopic visualization system of claim 1 wherein the valve preventsthe anti-fogging liquid solution from spilling out of the centralchamber when the distal end of the surgical scope is removed therefrom.13. The laparoscopic visualization system of claim 1 wherein a duckbillvalve is positioned at a level just above the level the liquid solutionreaches in the central chamber.
 14. A laparoscopic visualization systemcomprising, a shell to serve as an enclosure, the shell having a chamberfor holding a liquid into which a surgical scope can be inserted, aheating element in thermal transfer relationship with the chamber forwarming the liquid therein, wherein the central chamber comprises avessel having a wall surrounding a central compartment adapted tocontain the liquid with the heating element in thermal transferrelationship therewith, a thermoswitch in heat-conductive relationshipwith the vessel, and a wrapping material as a compression element forpressing the thermoswitch into close physical and thermal transferrelationship with the vessel.
 15. The laparoscopic visualization systemof claim 14 wherein the wrapping material is a circular pelliclesurrounding the vessel that presses against the outer surface of thethermoswitch for urging the thermoswitch toward the vessel.
 16. Thelaparoscopic visualization system of claim 14 wherein the thermoswitchincludes a thermal sensor element for opening an electrical circuit toan electrical power source when the thermoswitch reaches a selectedtemperature, and wherein the pellicle is a ring of thermoplasticresinous film that is shrunk onto the thermoswitch and the vessel by theapplication of heat thereto.
 17. The laparoscopic visualization systemof claim 14 including a printed circuit board connected to the vessel,the printed circuit board having circuit components selected from thegroup consisting of a resistor, an indicator light and an on/off switchand such components being conductively connected together by printedcircuit wiring applied to the circuit board.
 18. The laparoscopicvisualization system of claim 14 further comprising means for reducingpressure within the chamber when a distal end of the surgical scope isinserted into the chamber to keep liquid solution from being forced outof the chamber.
 19. The laparoscopic visualization system of claim 14wherein the heating element is a heating coil which is positionedbetween the central compartment and a layer of the wrapping materialwithin the housing.
 20. The laparoscopic visualization system of claim14 wherein the heating element is positioned below the level of liquidsolution within the chamber.